Trial Outcomes & Findings for Smart Linkage-to-HIV Care Via a Smartphone App (NCT NCT02756949)
NCT ID: NCT02756949
Last Updated: 2019-10-24
Results Overview
To test whether linkage to HIV care is improved by providing new HIV clients with access to a smartphone-enabled application (app) when compared to standard of care around 6 months post-diagnosis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
353 participants
Primary outcome timeframe
Recruitment +8 months
Results posted on
2019-10-24
Participant Flow
Participants were recruited at 5 public HIV testing sites (1 community health center, 3 clinics, and 1 tertiary hospital) in inner city Johannesburg, South Africa. Recruitment happened from October 2015 to June 2016. HIV positive individuals were pre-screened for trial suitability and recruited if eligible upon screening.
Of the 4537 individuals approached about the study, 90 declined to participate and 4094 were found ineligible during pre-screening and screening, leaving 353 for randomization. 8 standard of care arm participants were later removed from analysis due to erroneous sending of SMS reminders for their 6-month clinic appointment leaving 345 for analysis.
Participant milestones
| Measure |
Smartphone-enabled App for Linkage to Care
Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.
Smartphone application: Laboratory result data will be presented in the app with simple explanations on every screen. English and Zulu languages will be offered in the same app and written at a grade 4 reading level (as per WHO guidelines on literacy). Laboratory results will be supplemented with informative and relevant information explaining the result that has been shown and the recommended action for the patient to take. Patients will also be able to view additional HIV-related information and a Frequently Asked Questions (FAQ) through the app.
Smartphone
|
Standard of Care
Participants in this arm are randomised to receive standard of care services.
|
|---|---|---|
|
Overall Study
STARTED
|
181
|
172
|
|
Overall Study
COMPLETED
|
181
|
164
|
|
Overall Study
NOT COMPLETED
|
0
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Smartphone-enabled App for Linkage to Care
n=181 Participants
Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.
Smartphone application: Laboratory result data will be presented in the app with simple explanations on every screen. English and Zulu languages will be offered in the same app and written at a grade 4 reading level (as per WHO guidelines on literacy). Laboratory results will be supplemented with informative and relevant information explaining the result that has been shown and the recommended action for the patient to take. Patients will also be able to view additional HIV-related information and a Frequently Asked Questions (FAQ) through the app.
Smartphone
|
Standard of Care
n=164 Participants
Participants in this arm are randomised to receive standard of care services.
|
Total
n=345 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=181 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=345 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
181 Participants
n=181 Participants
|
164 Participants
n=164 Participants
|
345 Participants
n=345 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=181 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=345 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=181 Participants
|
103 Participants
n=164 Participants
|
224 Participants
n=345 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=181 Participants
|
61 Participants
n=164 Participants
|
121 Participants
n=345 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Africa
|
181 participants
n=181 Participants
|
164 participants
n=164 Participants
|
345 participants
n=345 Participants
|
|
Country of birth
|
181 Participants
n=181 Participants • Eight participants in the control arm were removed from analysis due to erroneous sending of SMS message to them leading to a contamination issue.
|
164 Participants
n=164 Participants • Eight participants in the control arm were removed from analysis due to erroneous sending of SMS message to them leading to a contamination issue.
|
345 Participants
n=345 Participants • Eight participants in the control arm were removed from analysis due to erroneous sending of SMS message to them leading to a contamination issue.
|
|
Education level
Primary only
|
8 Participants
n=181 Participants • Eight control arm participants excluded due to contamination of intervention
|
6 Participants
n=164 Participants • Eight control arm participants excluded due to contamination of intervention
|
14 Participants
n=345 Participants • Eight control arm participants excluded due to contamination of intervention
|
|
Education level
Some secondary school
|
51 Participants
n=181 Participants • Eight control arm participants excluded due to contamination of intervention
|
44 Participants
n=164 Participants • Eight control arm participants excluded due to contamination of intervention
|
95 Participants
n=345 Participants • Eight control arm participants excluded due to contamination of intervention
|
|
Education level
Completed secondary school
|
98 Participants
n=181 Participants • Eight control arm participants excluded due to contamination of intervention
|
85 Participants
n=164 Participants • Eight control arm participants excluded due to contamination of intervention
|
183 Participants
n=345 Participants • Eight control arm participants excluded due to contamination of intervention
|
|
Education level
Attended/completed tertiary
|
24 Participants
n=181 Participants • Eight control arm participants excluded due to contamination of intervention
|
29 Participants
n=164 Participants • Eight control arm participants excluded due to contamination of intervention
|
53 Participants
n=345 Participants • Eight control arm participants excluded due to contamination of intervention
|
|
Employment status
Full time
|
82 Participants
n=181 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
79 Participants
n=164 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
161 Participants
n=345 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
|
Employment status
Part time
|
37 Participants
n=181 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
22 Participants
n=164 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
59 Participants
n=345 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
|
Employment status
Unemployed
|
49 Participants
n=181 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
40 Participants
n=164 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
89 Participants
n=345 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
|
Employment status
Self-employed
|
10 Participants
n=181 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
16 Participants
n=164 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
26 Participants
n=345 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
|
Employment status
Student
|
3 Participants
n=181 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
7 Participants
n=164 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
10 Participants
n=345 Participants • Measure Analysis Population Description: Eight control arm participants excluded due to contamination of intervention
|
PRIMARY outcome
Timeframe: Recruitment +8 monthsPopulation: Eight standard of care participants removed from analysis due to contamination of the intervention.
To test whether linkage to HIV care is improved by providing new HIV clients with access to a smartphone-enabled application (app) when compared to standard of care around 6 months post-diagnosis.
Outcome measures
| Measure |
Smartphone-enabled App for Linkage to Care
n=181 Participants
Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.
Smartphone application: Laboratory result data will be presented in the app with simple explanations on every screen. English and Zulu languages will be offered in the same app and written at a grade 4 reading level (as per WHO guidelines on literacy). Laboratory results will be supplemented with informative and relevant information explaining the result that has been shown and the recommended action for the patient to take. Patients will also be able to view additional HIV-related information and a Frequently Asked Questions (FAQ) through the app.
Smartphone
|
Standard of Care
n=164 Participants
Participants in this arm are randomised to receive standard of care services.
|
|---|---|---|
|
Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)
Linked to HIV care
|
88 Participants
|
74 Participants
|
|
Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)
Not linked
|
93 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: Recruitment +8 monthsTo test whether among individuals aged 18-30 years linkage to HIV care is improved by providing new HIV clients with access to a smartphone-enabled application (app) when compared to standard of care around 6 months post-diagnosis.
Outcome measures
| Measure |
Smartphone-enabled App for Linkage to Care
n=83 Participants
Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.
Smartphone application: Laboratory result data will be presented in the app with simple explanations on every screen. English and Zulu languages will be offered in the same app and written at a grade 4 reading level (as per WHO guidelines on literacy). Laboratory results will be supplemented with informative and relevant information explaining the result that has been shown and the recommended action for the patient to take. Patients will also be able to view additional HIV-related information and a Frequently Asked Questions (FAQ) through the app.
Smartphone
|
Standard of Care
n=69 Participants
Participants in this arm are randomised to receive standard of care services.
|
|---|---|---|
|
Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)
Linked to HIV care
|
44 Participants
|
22 Participants
|
|
Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)
Not linked
|
39 Participants
|
47 Participants
|
Adverse Events
Smartphone-enabled App for Linkage to Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60